Prospective external validation of a bladder cancer detection model

Area of Science:

• Urology
• Oncology
• Biomarkers

Background:

• Few studies integrate clinical prognostic factors with urinary biomarkers for bladder cancer risk prediction.
• A previously developed bladder cancer detection nomogram combined clinical features with the NMP22® BladderChek® test.

Purpose of the Study:

• To prospectively validate a bladder cancer detection nomogram in a cohort of patients presenting with hematuria.
• To assess the nomogram's utility for predicting urothelial bladder carcinoma.

Main Methods:

• Prospective enrollment of 381 patients evaluated for hematuria across three centers.
• Urological evaluation included history, examination, cystoscopy, cytology, and the NMP22 test.
• A logistic regression model compared clinical data with and without NMP22 and urinary cytology for urothelial bladder carcinoma prediction.

Main Results:

• Urothelial bladder carcinoma was detected in 6% of patients.
• Positive predictors included age >65, male gender, white ethnicity, gross hematuria, positive NMP22, and positive cytology.
• The nomogram achieved a predictive accuracy of 80.2% and demonstrated good calibration.

Conclusions:

• A highly accurate tool combining clinical factors and a urinary biomarker for bladder cancer detection was prospectively validated.
• This tool can assist in prioritizing urological referrals for patients with hematuria, potentially improving diagnostic timelines.